Regulatory Coordinator III (Remote)

Highly qualified candidates, residing in California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia, will be considered for remote work. Those that reside outside of these states will not be consideredThe Regulatory Coordinator III will provide supervision of other regulatory staff. Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. This role submits continuations, amendments, responds to questions, generates reports, and maintains files research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, or training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).Primary Duties and Responsibilities

Provides supervision of other regulatory staff.

Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.

Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.

Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.

Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.

Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.

Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.

Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.

Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.

May participate in internal auditing of regulatory documents.

May supervise Regulatory Coordinator I/II and/or provide training and education of other personnel.

May participate in centralized activities of the department or institution.

Requirements:

Bachelor's Degree

Five (5) years minimum of directly related experience.

#JobsWorking Title: Regulatory Coordinator III (Remote)Department: SOCCI Clinical Research OfficeBusiness Entity: Cedars-Sinai Medical CenterJob Category: Compliance/QualityJob Specialty: Research CompliancePosition Type: Full-timeShift Length: 8 hour shiftShift Type: DayBase Pay: $78,400.00 - $133,100.00Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.